This study will determine the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients that are not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study will consist of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects will receive BAF312 treatment.

Received corticosteroids with or with out disease modifying antirheumatic drugs at least 3 months before study however not responding to this therapy

Exclusion Criteria:

Other idiopathic inflammatory myopathies

Myopathy other than polymyositis and dermatomyositis

Patients with late stages of disease Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148810